BridgeMD
New treatment option for Achalasia
Official title POEM-F for Achalasia International Study
ClinicalTrials.gov ID: NCT06042127
What this study is testing
- What it's testing
- Per-oral endoscopic myotomy (POEM) has emerged as the endoscopic treatment of choice for achalasia, offering comparable symptom relief with laparoscopic Heller's cardiomyotomy. The main concern with POEM is the higher incidence of post-procedure gastroesophageal reflux disease (GERD), occurring in up to 50-60% of patients.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II.
- Capability of understanding and complying with the study requirements, including filling the Eckardt Score, GERD-HRQL and RSI questionnaire and...
- Patients with achalasia type I, II or III who are one of the following:
- Treatment naïve, or
- Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation
You likely can't join if
- Patients unable or unwilling to provide consent.
- Previous esophageal or gastric surgery.
- Prior achalasia treatment including Heller myotomy, POEM.
- Sigmoid achalasia, or significant esophageal dilatation \>6cm in lower esophagus
- Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc
- Patients with large hiatal hernias (axial length \> 2 cm and Hill grade \>2).
See the full eligibility criteria
- Adult patient (age ≥18 and ≤65 years-old) and with symptomatic achalasia type I or II.
- Capability of understanding and complying with the study requirements, including filling the Eckardt Score, GERD-HRQL and RSI questionnaire and signing the informed consent form.
- Patients with achalasia type I, II or III who are one of the following:
- Treatment naïve, or
- Failed prior through-the-scope balloon dilation, Savary or pneumatic dilation
- Patients unable or unwilling to provide consent.
- Previous esophageal or gastric surgery.
- Prior achalasia treatment including Heller myotomy, POEM.
- Sigmoid achalasia, or significant esophageal dilatation \>6cm in lower esophagus
- Disrupted mucosal integrity at the distal esophagus, eg. Ulcer, fibrotic scars etc
- Patients with large hiatal hernias (axial length \> 2 cm and Hill grade \>2).
- Patients with significant cardiorespiratory comorbidities which may limit their ability to undertake general anesthesia for the procedure, including ASA grade III or above.
- Patients with obesity (Body Mass Index (BMI) ≥ 30).
- Pregnant women or those planning pregnancy or breastfeeding women.
- Uncorrectable coagulopathy defined by international normalized ratio (INR) \> 1.5 or platelet count \< 50000/µl.
The study team makes the final eligibility decision.
Where it's taking place
- Baltimore, Maryland, United States
- Guangzhou, China
- Hong Kong, Hong Kong
- Chandigarh, India
- Hyderabad, India
- Mumbai, India
- Pune, India
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Baltimore, Maryland, United States; Guangzhou, China; Hong Kong, Hong Kong; Chandigarh, India; Hyderabad, India; Mumbai, India and 1 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.